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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vapocoolant Device
510(k) Number K172598
Device Name Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE
Applicant
ITW Contamination Control Electronics
8125 Cobb Center Drive
Kennesaw,  GA  30152
Applicant Contact Steve Cook
Correspondent
ITW Contamination Control Electronics
8125 Cobb Center Drive
Kennesaw,  GA  30152
Correspondent Contact Steve Cook
Classification Product Code
MLY  
Date Received08/29/2017
Decision Date 04/19/2018
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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